跳至主要内容
临床试验/NCT07515651
NCT07515651尚未招募2 期

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Radiation-induced Acute Grade ≥2 Toxicity

研究概览

简要总结

This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan.

This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 & IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.

研究设计

研究类型
干预性
分配方式
不适用
干预模型
单组
主要目的
治疗
盲法
开放(无盲法)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • Age ≥ 18 years old.
  • Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
  • Radical prostatectomy > 6 months prior to commencing SBRT.
  • Biochemical relapse with local and/or regional recurrence proven with PSMA PET
  • ECOG 0-1.

排除标准

  • Presence of para-aortic lymph nodes or distant metastasis.
  • Chronic pelvic inflammatory disease.
  • Contraindication for radiation treatment.
  • Previous radiation treatment within the pelvis.

研究组 & 干预措施

Molecular Imaging Informed Radiation Dose Escalation and De-escalation

Experimental

Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.

干预措施: Image-guided Radiotherapy (Radiation)

结局指标

主要结局

Radiation-induced Acute Grade ≥2 Toxicity

时间窗: Baseline to 5-year follow up

Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

次要结局

  • Acute and Late GI and GU toxicities(Estimated at 6 months and 2 years following treatment)
  • Local Recurrence(Estimated at 2 years and 5 years following treatment)
  • Biochemical Disease Free Survival(Estimated at 2 years and 5 years following treatment)
  • Patient-reported quality-of-life assessed by EPIC-26 and IPSS(Baseline to 5-year follow-up)

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

Loading locations...

标识符

NCT 编号
NCT07515651
其他研究编号
25-6057

日期

首次提交
(6个月前)
首次发布
(5个月前)
主要完成日期
(8年后)
研究完成日期
(8年后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
是否有结果
否

相似试验